A Multicenter Randomized Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regiments in Subjects with Moderately Severely Active Crohn's Disease and Evidence of Mucosal Ulceration
ID Number 14-0904Principal Investigator(s)
James F Marion
This is a randomized double-blind multicenter study of two adalimumab induction regimens in subjects with moderately to severely active Crohn's Disease (CD) with evidence of mucosal ulceration confirmed by central reading. No placebo arm is planned since there is well-documented efficacy of adalimumab in CD and because the purpose of this study is to achieve better efficacy than the standard induction regimen in terms of clinical remission and endoscopic improvement. Additionally since subjects will be required to have failed or been intolerant of standard therapies and have evidence of endoscopic damage confirmed by a central reader, it would be not medically acceptable to deny those subjects effective treatment or feasible to enroll subjects in the trial when adalimumab is available to be prescribed for CD.
The primary objective of this study is to assess the efficacy and safety of two adalimumab induction regimens in achieving clinical remission (CDAI < 150) at Week 4 and endoscopic improvement defined as Simplified Endoscopic Score for Crohn's Disease (SES-CD) = 4 with an Ulcerated Surface subscore no greater than 1 in any segment at Week 12 in subjects with moderately to severely active Crohn's disease and evidence of mucosal ulceration. Subjects will receive under the skin injections (SC) of study drug.
At Week 0 volunteers will be randomized into one of two study groups:
- Standard induction regimen: adalimumab sc starting with a dose of 160 mg at Baseline and matching placebo at Week 1 followed by 80 mg at Week 2 and matching placebo at Week 3.
- Higher induction regimen: adalimumab sc a dose of 160 mg weekly at Weeks 0 1 2 and 3.
The number of people expected to take part in this research study at this site is 10. The total number of people expected to take part in this research study is 300. Their participation in this research study is expected to last to approximately 15 weeks and include 7 study visits to the study center.
Recruiting Patients: Yes